FDA Approves New Antibiotic for Complicated Urinary Tract Infections

For most people with urinary tract infections (UTIs), a short course of antibiotics is the go-to treatment. But for complicated urinary tract infections — severe bacterial illnesses that are resistant to different forms of antibiotics — this may not be adequate.

Now people with difficult-to-treat UTIs have a new medication option: The FDA has approved an antibiotic pill called Utebzi (tebipenem pivoxil).

Developed by GlaxoSmithKline (GSK) in collaboration with Spero Therapeutics, Utebzi is an oral form of an antibiotic class called carbapenems, a standard treatment for complicated UTIs. Before Utebzi, people with complicated UTIs could only get carbapenems intravenously.

“While the oral form of this antibiotic is not more efficacious or safe than the intravenous alternative, it is more convenient and can avoid the need for hospitalization or home intravenous administration,” says Craig Comiter, MD, the clinic chief of urologic specialties at Stanford University in Palo Alto, California. “This makes a valuable treatment option for complicated UTIs slightly easier to prescribe.”

Dr. Comiter expects that once Utebzi becomes available (by the end of this year, according to GSK), it will also lead to cost savings because it may reduce the time needed for hospitalization or missed work.

What Are Complicated UTIs?

The vast majority of urinary tract infections are not complicated and cause minor symptoms, such as burning during urination. These infections may affect the kidneys, bladder, ureters (tubes that carry urine from the kidneys to the bladder), and urethra (the tube that delivers urine out of the body from the bladder), but most clear the body after a short course of oral antibiotics.

Complicated UTIs are different. They are much more serious and harder to treat. The symptoms can extend throughout the body, and may include:

Fever
Chills
Nausea
Vomiting
Dehydration
Fatigue
Lower back pain

These more severe infections often require hospitalization. They may affect pregnant women, individuals with catheters, people with weakened immune systems, and those who have recently had surgery. They can result in bloodstream infection, kidney failure, and pregnancy complications.

Every year, U.S. healthcare practitioners diagnose more than three million complicated UTI cases, including kidney infections (pyelonephritis). These infections are often drug-resistant and treatments fail in more than a third of patients by some estimates.

An Oral Alternative to IV Medication

Amanda Peppercorn, MD, vice president of clinical development at GSK, calls carbapenems “a backbone for the treatment of severe infections in the hospital.”

These antibiotics work by interfering with the bacterial cell wall, killing the germ and clearing the infection.

“These medications are exclusively for very serious infections caused by bacteria with a lot of resistance,” says Dr. Peppercorn. “This drug brings the first oral carbapenem to market, so it allows patients — once they’ve stabilized from a very severe infection — to be able to be treated with an oral carbapenem, so that they can go home earlier or possibly avoid hospitalization.”

Patient Trials Show Significant Effectiveness

The FDA based its approval of Utebzi on results from a study involving nearly 1,700 adults hospitalized with complicated urinary tract infections. Over the course of 7 to 10 days, patients were randomly assigned to receive 600 milligrams (mg) of Utebzi orally every six hours or 500 mg of an intravenous form of carbapenem every six hours.

Those taking the pill had an overall success rate of almost 60 percent — about the same success rate as those receiving the IV administration.

About 90 percent of patients in both groups “felt better and had no clinical symptoms,” according to Peppercorn.

The chances of side effects were also similar in each group, with 3 percent or fewer reporting mild, moderate, and nonserious events such as diarrhea and headache.

While Utebzi is expected to be available to consumers by the end of 2026, Peppercorn notes that details regarding its pricing and insurance coverage are yet to be worked out.